FDA bill up in the air over proposed changes
By: Brett Norman
April 25, 2012 12:01 AM EST

The only health legislation that has any chance of passing before the elections this fall will be marked up by both chambers later this week, but key differences over proposed amendments to the FDA user fee bill in the House and Senate could lead to a protracted fight.

First up: House Republicans have proposed changing the FDA’s mission statement from its historic focus on ushering safe, new medical products to market to also considering the economic impact of its decisions to approve or deny drugs and devices.

Republicans have been talking about such a change during hearings over the past year, but the FDA is deeply opposed and the idea has not caught on in the Senate. The Senate Health, Education, Labor and Pensions Committee posted its chairman’s mark of the user fee bill Monday with no such changes to the mission statement.

“We are concerned that that could have unintended consequences in terms of the time it would take FDA to make those economic assessments,” said Allan Coukell, director of medical programs at the Pew Health Group, echoing comments made by FDA officials at recent hearings. “Then there’s the question, for instance, of what you do about a new beneficial product that costs jobs in the competition. This is not FDA’s job.”

That big-picture point could be cleared up when a chairman’s mark from the House Energy and Commerce Health Subcommittee comes out ahead of its markup on Thursday.

But some of the finer grain details are likely to cause contention as the bills progress.

For instance, both bills include language to spur development of new antibiotics that are effective against drug-resistant germs, and there is substantial bipartisan support for expanded protection against generic competition — or exclusivity — to some antibiotic drugmakers. But disagreement arises over whether those incentives will apply only to drugs that treat “serious or life-threatening conditions,” as the Senate bill does, or to almost any antibiotic, as House Republicans prefer.

Generally, both consumer and industry groups say that the HELP bill has been painstakingly negotiated over at least the past year with all of the stakeholders. Nobody got everything they wanted, but all sides can live with it. The committee is soliciting letters of support to that effect from consumer, patient and industry groups in an effort to project consensus.

“Ultimately, the bill is disappointing because it does not make much progress on the public health issues we care about,” said Diana Zuckerman, president of the National Research Center for Women & Families. For instance, Rep. Ed Markey (D-Mass.) and others wanted to give the FDA new authority to reject applications for devices that are based on their “substantial equivalence” to earlier devices that were found to be flawed and recalled, but that effort died.

“But HELP has been very inclusive to all the parties, and to some extent, nobody is real happy with the bill, which, as they say, is a good compromise,” Zuckerman said.

AdvaMed’s J.C. Scott, head of government relations for the medical device trade association, agreed.

“On balance, we are very encouraged by the Senate draft that we saw [Monday] and are working with the committee to encourage the process moving forward,” he said, adding that the group was drafting a letter of support. The HELP bill will be marked up on Wednesday and is scheduled to go to the floor in May.

Now all eyes are on the House. An Energy and Commerce Committee spokesperson said the user fee markup would happen this week but did not specify which day or when the chairman’s mark would be released.

In addition to the general areas of agreement, the House bill is widely expected to contain more industry-friendly provisions, especially for medical device makers. That could cause friction.

One in particular is the HELP bill’s efforts to streamline the FDA’s ability to reclassify the risk level of devices. Whether a device is deemed more, or less, risky can dramatically change the amount of clinical data and other studies required for approval.

Currently, such reclassification is a long-term rulemaking process that must be cleared by Health and Human Services and the Office of Management and Budget along with the full complement of public hearings and comment periods. The HELP bill would turn that into a faster administrative process without the extra layers of oversight.

AdvaMed is still pushing something in between. “We want to preserve some of our due process rights,” Scott said.